MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH HF UNIT "ESG-400"; ELECTROSURGICAL GENERATOR ESG-400

Model Number WB91051W

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Internal Organ Perforation (1987)

Event Date 11/28/2023

Event Type  Injury  

Event Description

A company representative, on behalf of the customer, reported a loud ding from the hf unit "esg-400" during a therapeutic transurethral resection of a bladder tumor.The doctor was using a bipolar loop and the esg-400.When the doctor heard the loud noise from hf unit "esg-400" there was a glitch and the doctor perforated the bladder.The patient was transferred to another room for a cystogram.The initial case was aborted and the equipment was quarantined.This medwatch requires two reports.The related patient identifiers are as follows: (b)(6) : hf unit "esg-400".(b)(6) : hf-resection electrode "plasmaloop", loop, large, 24 fr., 12°-30°, esg turis.This medwatch represents (b)(6).

• Brand Name: HF UNIT "ESG-400"
• Type of Device: ELECTROSURGICAL GENERATOR ESG-400
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• MDR Report Key: 18389728
• MDR Text Key: 331298508
• Report Number: 2429304-2023-00406
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/28/2023,12/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: WB91051W
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/28/2023
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/28/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HF-RESECTION ELECTRODE "PLASMALOOP"
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White